Ignite Creation Date:
2024-05-06 @ 12:22 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01555814
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2011-09-19
Brief Title:
Optimization of Treatment and Management of Schizophrenia in Europe OPTIMISE Substudy Site Copenhagen
Sponsor:
Birte Glenthoj
Organization:
University of Copenhagen
Study Overview
Official Title:
Optimization of Treatment and Management of Schizophrenia in Europe OPTIMISE the Effects of D2 Antagonism on Candidate Endophenotypes
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators want to relate disturbances in first-episode schizophrenic patients in dopaminergic D2 receptors brain structure brain function and information processing to each other and to psychopathology Additionally the investigators want to examine the influence of D2 receptor blockade on these disturbances The investigators expect disturbances in the dopaminergic system at baseline to correlate with specific structural and functional changes and with disruption in information processing as measured with psychophysiological and neurocognitive methods - and investigators expect D2 receptor blockade to reverse some of the functional and cognitive impairments The investigators do not expect any effect of treatment on brain structure
Detailed Description:
The study is designed as a 4 week case-control follow-up study of 90 FE pt with SCZ and 90 controls matched with regard to age gender and parental socio-economic status All subjects will be examined with a diagnostic interview SCAN Schedule for Clinical Assessment in Neuropsychiatry medical and family history and physical examination before inclusion At baseline subjects will be examined with single photon emission computed tomography SPECT MRI fMRI psychophysiology neurocognition In addition they will be screened for drugs genetic testing and ECG Patients will further be examined with clinical validated rating scales to measure psychopathology subjective well-being and side-effects After a period of 4 weeks all assessments are repeated During that period patients will be treated with amisulpride while healthy controls will receive no treatment at all Efficacy of antipsychotic treatment will be evaluated after this initial period of 4 weeks All subjects will be re-assessed in the same test battery as mentioned above except for SPECT and fMRI after a period of 6 12 and 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None